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RecruitingNCT07459504Updated Jun 1, 2026

SMART Diets for MASLD

A Phase 2 interventional study of Essential Amino Acids Supplementation intervention and Low sugar diet in Metabolic-dysfunction Associated Steatotic Liver Disease, sponsored by Michigan State University. Recruiting at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Michigan State University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.

Read the detailed description

Metabolic-dysfunction associated steatotic liver disease is defined as the presence of abnormal hepatic stored triglycerides (hepatic steatosis), with one or more of 5 cardiometabolic factors (increased body mass index or waist circumference, hyperglycemia, hypertriglyceridemia, or low HDL) and no other chronic liver disease. Pediatric hepatic steatosis is central to long-term metabolic and cardiovascular health because of the relation of hepatic steatosis to the development of other major diseases. Hepatic steatosis limits the normal metabolic role of insulin and plays a key role in the future development of the metabolic syndrome, and is the strongest predictor for the development of type 2 diabetes.

02

Conditions studied

  • Metabolic-dysfunction Associated Steatotic Liver Disease

Keywords

  • MASLD
  • Adolescents
  • Liver
  • Sugar
  • Amino acid supplement
03

In context

Lead sponsor

Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children 11 to 17-years-old at the time of consenting
  • Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
  • At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age/sex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130/80 and/or signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU/mL in prepubertal children and of 17 pIU/mL and 13 pIU/mL in pubertal girls and boys, respectively, OR Prediabetes)
  • ALT greater than or equal to 40 U/L
  • Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.
  • Patients of childbearing potential agrees to use adequate one or more effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Patients who are taking medications that can affect insulin (e.g., metformin, corticosteroids), most be on a stable dosage for at least 3 months prior to enrollment of the trial.
  • Written informed consent from parent or legal guardian, assent from child.

Exclusion criteria

Exclusion Criteria:

  • Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of >6.5 mg/dL at baseline
  • Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.
  • Patients unable to complete MRI or Labs required for the study.
  • Current participation in another clinical trial
  • Current participation in a weight loss program or obesity treatment program or clinic
  • Cancer or history of cancer within 5 years
  • Severe illness that required hospitalization in the last 60 days
  • Use of medications known to cause liver steatosis (TPN, amiodarone, chronic oral steroids, etc.)
  • Patients with implanted metal devices that are not compatible with magnetic resonance imaging (MRI).
  • Intellectual disability or major psychiatric disorder limiting informed assent
  • Clinical evidence of cirrhosis or advanced liver disease by any one of the following abnormal labs: (Hemoglobin less than 10 g/dL, White blood cell less than 3,500 cells/mm, Neutrophil count less than 1,500 cells/mm3 of blood, Platelets less than 130,000 cells/mm3 of blood, Direct bilirubin greater than 1.0 mg/dL)
  • Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range.
  • Albumin less than 3.2 g/dL
  • A history of international normalized ratio (INR) greater than 1.4
  • AST or ALT greater than 250 IU/dL.
  • Compensated or decompensated cirrhosis with evidence of portal hypertension.
  • Patients is pregnant or breastfeeding.
  • Patients who have been enrolled in a recent clinical trial and had the last dose of investigational product within 30 days or 5 half-lives of the study drug, whichever is longer.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    Essential Amino Acids Supplementation

    The essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase.

    Drug: Essential Amino Acids Supplementation intervention

  • Active comparator
    Low Sugar Diet

    The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.

    Other: Low sugar diet

Interventions

  • DrugEssential Amino Acids Supplementation intervention

    EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine

    Also known as: EAA, AMS2392

  • OtherLow sugar diet

    The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.

06

What researchers measure

Primary outcomes

  1. Change in hepatic steatosis

    Change in hepatic steatosis by magnetic resonance imaging (MRI)

    Time frame: Baseline to 24 weeks

Secondary outcomes

  1. Change in fasting triglyceride

    Change in triglyceride in mg/dL

    Time frame: Baseline, 12 and 24 weeks

  2. Change in HDL

    Change in HDL mg/dL

    Time frame: Baseline, 12 and 24 weeks

  3. Change in VLDL-triglyceride

    Very-low-density-lipoprotein triglyceride

    Time frame: Baseline, 12 and 24 weeks

  4. Change in Waist circumference

    Change in Waist circumference in cm

    Time frame: Baseline, 12 and 24 weeks

  5. Change in body weight

    Change in weight in kilograms

    Time frame: Baseline, 12 and 24 weeks

  6. Change in BMI Z Score

    Change in body mass index z-score

    Time frame: Baseline, 12 and 24 weeks

  7. Change in Alanine Aminotransferase (ALT)

    Change in ALT

    Time frame: Baseline, 12 and 24 weeks

  8. Aspartate Aminotransferase (AST)

    Change in AST

    Time frame: Baseline, 12 and 24 weeks

  9. Gamma glutamyl transferase (GGT)

    Change in GGT

    Time frame: Baseline, 12 and 24 weeks

  10. Systolic blood pressure

    Change in systolic blood pressure mg/dL

    Time frame: Baseline, 12 and 24 weeks

  11. Diastolic blood pressure

    Change in diastolic blood pressure (mg/dL)

    Time frame: Baseline, 12 and 24 weeks

  12. Hemoglobin A1c

    Change in hemoglobin A1c

    Time frame: Baseline, 12 and 24 weeks

  13. HOMA-IR

    Change in homeostatic model assessment of insulin resistance (HOMA-IR)

    Time frame: Baseline, 12 and 24 weeks

  14. Adverse events

    Number of adverse events compared between arms of the study

    Time frame: Baseline, 12 and 24 weeks

  15. Percent responders

    Percent of participants who reduce hepatic steatosis in the group that start with low sugar diet compared to the group that starts with EAA intervention

    Time frame: Baseline to 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Corewell Health West
    Grand Rapids, Michigan 49503, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The proposed research will include data from approximately 102 participants at up to 3 time-points. The final scientific datasets will include intervention assignment, anthropometrics, laboratory and imaging data. All protected health information and personally identified information will be removed. The study dates will be removed. Scientific data from the primary and secondary endpoints, along with a detailed data dictionary, and study protocols will be made available on a data repository such as Emory DataVerse. Genetic information for participants will not be made available.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07459504
Lead sponsor
Michigan State University
Collaborators
Emory University, Corewell Health West, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Miriam B. Vos (Principal Investigator, Michigan State University) — Principal investigator
First posted
Mar 9, 2026
Start date
Jun 2026 (estimated)
Primary completion
Dec 26, 2029 (estimated)
Completion
Dec 26, 2030 (estimated)
Last update
Jun 1, 2026

Study contacts

Miriam B Vos, MD, MSPH
Contact
miriam.vos@msu.edu
616-267-2100
Miriam B Vos, MD, MSPH
principal investigator · Michigan State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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